Myriad has expanded its companion diagnostic collaboration with AstraZeneca and MSD, a partnership that dates back to 2007.
Under the expanded collaboration, the companies will use BRACAnalysis CDx to identify germline BRCA mutations in men who have metastatic castrate-resistant prostate (mCRPC) cancer and are enrolled in the Phase III PROfound (NCT02987543) study.
In the event of a successful study, Myriad intends to file a supplementary premarket approval application with the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as a companion diagnostic to Lynparza (olaparib).
"Our companion diagnostic collaboration with AstraZeneca and Merck has led to significant advancements in precision treatment for patients with ovarian, breast cancer,” said Nicole Lambert, president, Myriad Oncology.
“However, there is a significant unmet medical need in men with metastatic castration-resistant prostate cancer and BRCA1/2 mutations, which is an area where the utility of PARP inhibitors is being explored. We look forward to this exciting opportunity to potentially expand the use of BRACAnalysis CDx in this setting."
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes.